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Background <p>Metabolic dysfunction-associated steatotic liver disease (MASLD) is among the most common chronic liver diseases worldwide [1], and its targeted therapy and new drug development have drawn extensive global attention. Prior relevant studies mainly focus on the clinical efficacy and economic returns of MASLD drugs, rarely covering social and environmental impacts across the drug R&amp;D lifecycle. This study aims to fill this research gap by evaluating MASLD drug development risks from a sustainable accounting perspective with triple bottom line indicators.</p> Methods <p>Based on the sustainable accounting framework covering economic, social and environmental dimensions, this paper analyzes the global MASLD drug R&amp;D landscape. It adopts annual report data and core product information of four typical listed pharmaceutical companies: Madrigal, Huadong Pharmaceutical, Novo Nordisk and Inventiva. This study systematically compares five representative MASLD therapeutic agents and candidates, including resmetirom, semaglutide, DR10624, lanifibranor and HTD1801, in terms of pharmacological mechanisms, clinical performance, R&amp;D costs and commercial prospects, including thyroid hormone receptor agonists, GLP-1 receptor agonists, multi-target agonists, pan-PPAR agonist and entero-hepatic system modulators. Based on the Delphi consensus, In the main text, the name chosen to replace MASH, MAFLD, NASH and NAFLD is metabolic dysfunction-associated steatotic liver disease (MASLD).</p> Results <p>Three key sustainable risks exist in current MASLD drug development. Economically, high R&amp;D costs lead to expensive marketed drugs and uncertain cost-effectiveness. At the economic level, resmetirom has a reported ICER of US$140,134/QALY, while semaglutide shows lower ICERs of US$42,200/QALY and US$44,138/QALY, respectively. Socially, uneven drug accessibility across regions and income groups, low grassroots diagnosis rates and unpopular interdisciplinary treatments cause missed early intervention opportunities for patients. Environmentally, green R&amp;D technologies are poorly promoted, small and medium-sized drug enterprises face resource constraints, and quantitative life-cycle assessment data remain limited for the MASLD drugs reviewed, making it difficult to clarify long-term ecological risks of drug residues.</p> Conclusions <p>The three bottom lines of economy, society, and environment are interconnected and are the core criteria for measuring sustainable research and development of MASLD drugs. The industry still needs to address issues such as economic returns, medical fairness, and ecological protection. By optimizing R&amp;D layout, improving medical insurance policies, and perfecting the drug lifecycle environmental evaluation system, the industry can ultimately achieve sustainable development of MASLD pharmaceuticals.</p>

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Analysis of drug development risks for metabolic dysfunction-associated steatotic liver disease from a sustainable accounting perspective

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月4日

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  • Xiyan Liu,
  • Mohammed Mirza

摘要

Background

Metabolic dysfunction-associated steatotic liver disease (MASLD) is among the most common chronic liver diseases worldwide [1], and its targeted therapy and new drug development have drawn extensive global attention. Prior relevant studies mainly focus on the clinical efficacy and economic returns of MASLD drugs, rarely covering social and environmental impacts across the drug R&D lifecycle. This study aims to fill this research gap by evaluating MASLD drug development risks from a sustainable accounting perspective with triple bottom line indicators.

Methods

Based on the sustainable accounting framework covering economic, social and environmental dimensions, this paper analyzes the global MASLD drug R&D landscape. It adopts annual report data and core product information of four typical listed pharmaceutical companies: Madrigal, Huadong Pharmaceutical, Novo Nordisk and Inventiva. This study systematically compares five representative MASLD therapeutic agents and candidates, including resmetirom, semaglutide, DR10624, lanifibranor and HTD1801, in terms of pharmacological mechanisms, clinical performance, R&D costs and commercial prospects, including thyroid hormone receptor agonists, GLP-1 receptor agonists, multi-target agonists, pan-PPAR agonist and entero-hepatic system modulators. Based on the Delphi consensus, In the main text, the name chosen to replace MASH, MAFLD, NASH and NAFLD is metabolic dysfunction-associated steatotic liver disease (MASLD).

Results

Three key sustainable risks exist in current MASLD drug development. Economically, high R&D costs lead to expensive marketed drugs and uncertain cost-effectiveness. At the economic level, resmetirom has a reported ICER of US$140,134/QALY, while semaglutide shows lower ICERs of US$42,200/QALY and US$44,138/QALY, respectively. Socially, uneven drug accessibility across regions and income groups, low grassroots diagnosis rates and unpopular interdisciplinary treatments cause missed early intervention opportunities for patients. Environmentally, green R&D technologies are poorly promoted, small and medium-sized drug enterprises face resource constraints, and quantitative life-cycle assessment data remain limited for the MASLD drugs reviewed, making it difficult to clarify long-term ecological risks of drug residues.

Conclusions

The three bottom lines of economy, society, and environment are interconnected and are the core criteria for measuring sustainable research and development of MASLD drugs. The industry still needs to address issues such as economic returns, medical fairness, and ecological protection. By optimizing R&D layout, improving medical insurance policies, and perfecting the drug lifecycle environmental evaluation system, the industry can ultimately achieve sustainable development of MASLD pharmaceuticals.